NDC 75921-121 Meclizine Hydrochloride

NDC Product Code 75921-121

NDC 75921-121-30

Package Description: 30 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Meclizine Hydrochloride with NDC 75921-121 is a product labeled by Life Line Home Care Services, Inc.. The generic name of Meclizine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Life Line Home Care Services, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Life Line Home Care Services, Inc.
Labeler Code: 75921
Start Marketing Date: 06-04-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Meclizine

Meclizine is pronounced as (mek' li zeen)

Why is meclizine medication prescribed?
Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.This medication is ...
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Meclizine Hydrochloride Product Label Images

Meclizine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and
25 mg. In addition each tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium
Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg
contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP,
25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).

Clinical Pharmacology

Meclizine Hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Indications And Usage

For the management of nausea and vomiting, and dizziness associated with motion sickness.

Contraindications

Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Warnings

Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.Patients should avoid alcoholic beverages while taking this drug.Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.

Precautions

PREGNANCY, Teratogenic EffectsPregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that medicine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary. Pediatric UseClinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

Adverse Reactions

Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

Dosage And Administration

Motion SicknessThe initial dose of 25 to 50 mg of Meclizine HCI should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

How Supplied

Meclizine HCI Tablets, USP are available in the following strengths and package sizes:12.5 mg (Blue, oval-shaped, scored, debossed with TL122)Bottles of 100           NDC 59746-122-06Bottles of 1000         NDC 59746-122-1025 mg (Yellow, oval-shaped, scored, debossed with TL121)Bottles of 100            NDC 59746-121-06Bottles of 1000          NDC 59746-121-10Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature].Manufactured By:Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA.Revised 03/11

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